The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

Device Description

The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution through dual peristaltic independently operated pumps (one for blood, one for crystalloid). It monitors volume delivered, flow rate (adjustable from 0 - 990 ml/min), and pressure (line and external). It also includes temperature monitoring capabilities, gross air detection using ultrasonic technology, and two independent elapsed timers. The instrument has a color central information display and a two-stage alert-alarm process. It has battery backup for 60 minutes of "On" time and 15 minutes of pumping time. The disposable sets are single use, sterile, and nonpyrogenic, designed to mix arterial blood and asanguineous cardioplegia solution at various ratios. The sets include silicone tubing and polycarbonate connectors and are available in four configurations, with or without a heat exchanger and with standard or dual lumen patient lines.

AI/ML Overview

The Medtronic CSS Cardioplegia Safety System Model 990 is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than fully detailing a study against specific acceptance criteria for novel performance claims. However, it does present performance data for various features of the device as part of the substantial equivalence argument, which can be interpreted as meeting certain "acceptance criteria" by comparing them to predicate devices or manufacturer's specifications.

Here's an analysis of the acceptance criteria and the study as presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table where the Medtronic CSS's features and performance specifications are listed alongside those of predicate devices (Sorin BCC, Quest MPS, Sarns 9000). While it doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical claims, the comparison table implicitly defines the acceptable performance range by demonstrating equivalence to already cleared devices or meeting internal specifications.

Feature Area	Implicit Acceptance Criteria / Predicate Performance (Range from table)	Medtronic CSS Reported Device Performance	Study/Test Performed
Pressure Range	0-990 mmHg (Sarns); 0-550 mmHg (Sorin); 0-600 mmHg (Quest)	0-500 mmHg (Also, pump mechanism will not generate > 1200mmHg; shuts down if > 500 mmHg)	In-Vitro Bench Testing: Occlusion and Maximum Pressure, Line Pressure Measurement System Performance, External Pressure Measurement
Line Pressure Accuracy	+/- 5 mmHg (Sorin); +/-2.5% or 3mmHg (Quest); +/-10-20 mmHg (Sarns)	0-100 mmHg +/-10 mmHg; 101-500 mmHg +/-10%	In-Vitro Bench Testing: Line Pressure Measurement System Performance
External Pressure Accuracy	+/- 5 mmHg (Sorin); +/-2.5% or 3mmHg (Quest); +/-10-20 mmHg (Sarns)	0-100 mmHg +/- 5 mmHg; 101-500 mmHg +/-5%	In-Vitro Bench Testing: External Pressure Measurement
Constant Pressure Mode	Yes (Quest, Medtronic CSS); N/A (Sorin, Sarns)	Pressure maintained at +/-15% of target; flow varies no more than +/-25%	In-Vitro Bench Testing: Constant Pressure Mode Performance
Flow Rate	0-9.8 L/min (Sarns); 10-600 mL/min (Sorin); 0-500 mL/min (Quest)	0-990 mL/min	In-Vitro Bench Testing: Pump Flow Performance
Flow Accuracy	+/-5% (Sorin, Quest); +/-0.1-0.3 L/min (Sarns)	0-600 +/- 10% *; 601-990 +/- 20%	In-Vitro Bench Testing: Pump Flow Performance
Temperature Range	0-50°C (Medtronic CSS); 0-40°C (Sorin); 0-39°C (Quest); 0-49.9°C (Sarns)	0-50°C	In-Vitro Bench Testing: Temperature Monitoring
Temperature Accuracy	+/-1°C (Sorin, Quest, Medtronic CSS); +/-0.2°C (Sarns)	+/-1°C	In-Vitro Bench Testing: Temperature Monitoring
Timer Range	0-99hr59min59sec (Medtronic CSS); 0-99.9 min (Sorin); 0-24 hrs (Sarns)	0-99hr59min59sec	Not explicitly detailed, but part of functional testing
Timer Accuracy	1 sec (Medtronic CSS); 0.1 min (Sorin); +/- 1 min (Sarns)	1 sec	Not explicitly detailed, but part of functional testing
Gross Air Detection	Yes (Quest, Sarns, Medtronic CSS); No (Sorin)	Detects gross air (air bubble of at least 1/4" diameter)	In-Vitro Bench Testing: Gross Air Detection
Battery Back-up	Yes (Sorin, Sarns, Medtronic CSS); No (Quest)	60 min "On" time, 15 min pumping time	In-Vitro Bench Testing: Battery Back-up
Air Detection Transducer	Uses ultrasonic detection technology	Uses ultrasonic detection technology for gross air	In-Vitro Bench Testing: Gross Air Detection
Disposable Set Integrity	N/A (specific to Medtronic CSS)	Operated in accordance with Medtronic Bio-Medicus device specifications	In-Vitro Bench Testing: The CSS™ Instrument Disposable Set Integrity Test
Blood Trauma	N/A (specific to Medtronic CSS)	Operated in accordance with Medtronic Bio-Medicus device specifications	In-Vitro Bench Testing: Blood Trauma Test
Biocompatibility	Materials commonly used in medical industry; tested per FDA/ISO	Materials determined to be biocompatible and nontoxic	Biocompatibility Testing
Sterilization	N/A (specific to Medtronic CSS)	Validated 100% (EtO) at min SAL of $10^{-6}$ per ANSI/AAMI/ISO 11135-1994	Sterilization Validation
EtO Residuals	N/A (specific to Medtronic CSS)	Meets limits per ANSI/AAMI/ISO 10993-7:1995	EtO Residuals Testing
Pyrogen Testing	N/A (specific to Medtronic CSS)	Less than 0.5 EU/ml per FDA guidelines (Dec 1987)	Pyrogen Testing (LAL method)

* "Based on customer input this accuracy is sufficient for this application"

2. Sample Size Used for the Test Set and Data Provenance

The document describes "In-Vitro Bench Testing" and "Biocompatibility Testing."

Test Set Sample Size: Not explicitly stated for any of the individual bench tests. The document only lists the types of tests conducted. For biocompatibility, it states "these devices were tested," implying a sample was used but no number is provided.
Data Provenance: The tests described are "In-Vitro Bench Testing" and "Biocompatibility Testing." This indicates the data is from retrospective laboratory experiments conducted by the manufacturer, Medtronic Bio-Medicus, Inc. There is no mention of human subject data or data from specific countries of origin beyond the company's location in Eden Prairie, MN, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a cardioplegia delivery system, and the studies performed are bench tests and biocompatibility tests. There is no diagnostic component requiring human expert ground truth for interpretation of medical images or patient conditions. The "ground truth" for these tests would be the established engineering specifications, chemical/biological standards, and physical measurements.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for bench or biocompatibility testing. The "adjudication" would involve comparing test results against predefined engineering specifications and regulatory standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Medtronic CSS Cardioplegia Safety System is a therapeutic delivery system with monitoring capabilities, so an MRMC study is not relevant to its function and claims.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the "In-Vitro Bench Testing" and "Biocompatibility Testing" can be considered standalone performance evaluations. These tests assess the device's intrinsic mechanical, electrical, and material properties and performance against specifications without direct human-in-the-loop interaction for the specific performance endpoint being measured (e.g., pump flow accuracy, pressure detection, air bubble detection). The control system (microprocessor, software) within the instrument operates autonomously during these tests to fulfill its functions.

7. Type of Ground Truth Used

The ground truth for the various tests appears to be:

Engineering Specifications: For parameters like flow accuracy, pressure accuracy, temperature accuracy, timer accuracy, and constant pressure mode performance, the ground truth is the device's designed operational specifications and performance limits. These are then compared to the measured performance.
Physical Measurements: Directly measured flow rates, pressures, temperatures, and times.
Biological/Chemical Standards: For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1, USP XXIII) and FDA guidelines. For EtO residuals, it's ANSI/AAMI/ISO 10993-7:1995. For pyrogen testing, it's FDA guidelines.
Visual/Physical Detection: For gross air detection, the ground truth would be the presence of a known air bubble of a specified size.

8. Sample Size for the Training Set

Not explicitly stated. As this is a 510(k) for a hardware device with embedded software (not a machine learning/AI diagnostic system generating models from data), the concept of a "training set" in the context of statistical modeling or AI development is not directly applicable in the way it is for imaging algorithms. Any "training" or calibration would likely refer to internal iterative development and testing against specifications, rather than data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the typical AI/ML sense. For hardware and embedded software development, the "ground truth" during development (if we were to loosely interpret "training set" as development data) would be established by engineering design specifications, safety standards, and performance targets derived from clinical requirements and predicate device performance. This would involve rigorous internal testing, debugging, and verification to ensure the device performs as designed.

Summary

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K973237

SUMMARY OF SAFETY AND EFFECTIVENESS APR 27 1998

510(K) SUMMARY

COMPANY AND CONTACT PERSON

Medtronic Bio-Medicus, Inc. Cardiopulmonary Division 9600 West 76th Street Eden Prairie, MN 55344 tel. (612)944-7784 fax (612)944-7557

Thomas K. Johnsen Product Regulations Manager

TRADE NAME

Grand Cardioplegia Safety System Model 990.

COMMON, USUAL OR CLASSIFICATION NAME

The devices which comprise the CSS" Cardioplegia Safety System have been classified by the Cardiovascular Device Classification Panel as Class II devices.

21 CFR 870.4370 Roller type cardiopulmonary bypass blood pump

21 CFR 870,4240 Cardiopulmonary bypass heat exchanger

21 CFR 870.4390 Cardiopulmonary bypass pump tubing

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

Sorin Biomedical Inc. - Sorin Blood Cardioplegia Console (K942582) Quest Medical Inc. - Myocardial Protection System (K953838) Sarns Inc/3M - Sarns 9000 Heart Lung Console (K871131) Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755)

DESCRIPTION OF DEVICE

The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The details of these components are described below.

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Instrument: CSS " Cardioplegia Safety System Model 990

Peristaltic Pumps:

The CSS " Instrument delivers cardioplegia solution to the patients myocardium through a system of dual peristaltic independently operated pumps. One pump is dedicated for the delivery of blood, and the other pump is dedicated for the delivery of crystalloid solution. The dual roller pumps feature interlocks so that the disposable tubing sets can only be loaded one way. Each roller pump is designed with a mechanically spring loaded back to maintain constant pressure on the tubing (ensures flow accuracy). The spring loaded feature also allows the mechanical release of fluid pressure in the case of over pressurization . The pump mechanism will not generate a line pressure greater than 1200 mmHg. To ensure patient safety, the microprocessor will shut the unit down if the line pressure or external pressure exceeds 500 mmHg. The user may also set the pressure limits at values less than 500 mmHg which will alarm, and shut the unit down. Each roller pump head is equipped with an air detection transducer which uses ultrasonic detection technology that will detect gross air (air bubble of at least 1/4" diameter) entering the inlet side of each roller pump. This feature is used to alert the user of an empty cardioplegia bag, low fluid or no fluid conditions entering the roller pump.

Volume:

Cardioplegia solution can be delivered to the patient at a controlled volume by selecting the relative pump speed for the ratio of blood to cardioplegia solution.

The CSS Instrument monitors the volume of solution delivered. During typical clinical procedures, cardioplegia is delivered in phases. Therefore, the CSS instrument provides two volume counters. The function of these counters is as follows:

1. One volume counter reports the volume delivered during individual phases of operation. This counter can be reset to zero after each phase.
1. The other volume counter records and reports the total volume delivered for all phases of operation.

A total volume limit can be set by the user. If the total volume limit is exceeded then an alert condition is triggered.

Flow Rate:

The CSS Instrument is able to control solution flow rate by flow and by pressure. Solution flow rate is controlled by direct adjustment of the flow control knob (Manual mode), or the CSS" can deliver solution by a user-defined constant pressure setting (Constant pressure mode). The flow rate can be adjusted from 0 - 990 ml/min.

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Ratios:

Based on the patient's clinical need the ratio of blood to cardioplegia solution may vary (1:0, 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, & 0:1, 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9). Alternative blood-to-cardioplegia ratios may be made available, as warranted by clinical need. A Protocol mode of operation allows the user to customize and store up to 9 distinct cardioplegia protocols; protocol settings can be changed as determined by the user needs.

Temperature Monitoring:

When monitoring temperature of the cardioplegia heat exchanger, use a Medtronic Probe, Model 1384 which contains a YSI 400 Thermistor. If monitoring of the myocardium is desired, a Medtronic Blood Management Myocardial Needle Temperature Probe must be used. Two myocardial needles are available. The 2100 series Myocardial Needle requires the #9012-147T adapter, and the 2400 series Myocardial Needle requires the #9004 adapter.

Pressure Monitoring:

The CSS " Instrument monitors pressure at two sites;

1. at the CSS Instrument line pressure, and
1. at the cannulae - external pressure

Separate alert and alarm levels can be setup by the user for each of these sites.

Gross Air Detector:

Each roller pump head is equipped with an air detection transducer which uses ultrasonic detection technology that will detect gross air (air bubble of at least 1/4" diameter) entering the inlet side of each roller pump. This feature is used to alert the user of an empty cardioplegia bag, low fluid or no fluid conditions entering the roller pump.

Timers:

The CSS Instrument is also equipped with two independent elapsed timers to assist the operator in the management of cardioplegia delivery. One timer is typically used to monitor cross-clamp duration, and one timer is typically used to monitor cardioplegia delivery duration. The timers can be reset at any time for use in other applications.

Central Information Display:

The color central information display (CID) provides a constant indication of the instrument's operating state. Key-pad buttons adjacent to the display are used for setting adjustable parameters. The display shows running totals of solution volumes infused and provides both numeric and bar graph representation of

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pressure in mmHg or kPa. A configuration screen allows the user to select the language shown on the display, as well as the pressure measurement units, and the alarm tone.

Alarms and Alerts:

Safety features have been designed into the CSS " Instrument by initial power on and continual run-time software tests. The CSS Instrument has a two stage alert-alarm process. Alarms and alerts are presented both visually and audibly. If an alarm condition exists, the unit will automatically shut the roller pumps off until the alarm state is corrected.

Battery:

Battery operation, is automatically enabled in the case of AC power failure. This feature offers 60 minutes of "On" time (displays, and monitors), and 15 minutes of pumping time. The 15 minutes pumping time is the typical time of cardioplegia delivery during bypass surgery.

Hardware:

The CSS can be mounted in most conventional heart-lung systems, with the exception of heart-lung machines that require common air flow for the cooling of The CSS can also be mounted on a 1.00" to 1.75" diameter each module. horizontal pole. An adapter is provided for vertical pole mounting.

Instrument Accessory

The Graseby Medical Ltd., Model 3400 Anesthesia Syringe Pump 510(k) # K931318 can be connected to the CSS "Cardioplegia Safety System Model 990 by way of an RS232 port for administration of arresting agents (e.g. potassium).

Disposables

CSS" Cardioplegia Sets

The Medtronic® CSS" Cardioplegia Sets are designed to work specifically with the Medtronic® CSS" Cardioplegia Safety System, Model 990 instrument.

The CSS Cardioplegia Sets are single use, sterile and nonpyrogenic disposable devices designed to mix arterial blood from the cardiopulmonary bypass circuit with asanguineous cardioplegia solution at a variety of ratios, depending on clinical need. The CSS set is available in four configurations as follows:

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1. With CardioTherm™ Heat Exchanger and Standard patient line
1. With CardioTherm™ Heat Exchanger and Dual Lumen patient line
With Standard patient line No CardioTherm™ Heat Exchanger 3.
With Dual Lumen patient line No CardioTherm™ Heat Exchanger 4.

The components used in the CSS" Cardioplegia Sets are identical to the components used in the currently marketed CardioTherm" Blood Cardioplegia Systems (K960755). There are only two modifications to the CardioTherm Blood Cardioplegia System tubing sets. These modifications are:

silicone tubing set (with connectors) will be used as the pump header tubing, l) instead of polyvinyl chloride, and
the patient line can be either dual or single lumen, instead of just single lumen. 2)

The CardioTherm" Blood Cardioplegia Systems are currently manufactured, packaged and sterilized by Medtronic Cardiopulmonary, Anaheim, CA. The CSS" Cardioplegia Sets will be manufactured, packaged and sterilized by Medtronic Cardiopulmonary, Anaheim, CA.

Silicone Tubing and Polycarbonate Connectors

Cardioplegia Set will include medical grade silicone tubing with Each CSS polycarbonate connectors to facilitate the insertion of the tubing into the roller Silicone tubing offers two distinctive advantages over polyvinyl pump head. chloride tubing when used in the roller pump. These advantages are:

1. Less temperature sensitivity which offers more consistent and accurate flow (the pliability of polyvinyl chloride tubing tends to be affected by temperature change),
1. Allows measurement of line pressure through the silicone tubing by means of the line pressure transducers mounted in the roller pump. This eliminates the need for additional in-line components.

The internal diameter of the CSS Cardioplegia Set silicone pump header tubing will not vary since the blood to solution ratios are controlled by the speed of the roller pumps.

Dual Lumen Patient Line

The dual lumen patient line is identical in material composition to the standard lumen patient line. The dual lumen patient line is tubing extruded with two separate lumens, one for the cardioplegia delivery, and the other for external pressure monitoring.

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INTENDED USE OF THE DEVICE

The Medtronic CSS " Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

INTENDED USE OF PREDICATE/MARKETED DEVICES

Sorin Blood Cardioplegia Console ("BCC")

The Sorin Blood Cardioplegia Console ("BCC") is intended for use by qualified personnel during cardiopulmonary bypass procedures to control and monitor the introduction of blood and/or crystalloid in the management of cardioplegia.

Quest MPS Myocardial Protection System

The Quest MPS myocardial protection system is intended for use by perfusionists and surgeons trained in delivering cardioplegia solution to the myocardium during open heart surgery

Sarns 9000 Perfusion System

The Sarns 9000 Perfusion System is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. With Cardioplegia Control Module installed, the 9000 system is indicated to pump a set volume of cardioplegia fluid at a set pressure during cardiopulmonary bypass procedures.

Medtronic CardioTherm™ Blood Cardioplegia System (Disposable)

The Medtronic CardioTherm" Blood Cardioplegia System is intended for the mixing, cooling, warming and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

SUBSTANTIAL EQUIVALENCE

The Medtronic CSS" Cardioplegia Safety System is substantially equivalent to other cardioplegia systems currently in commercial distribution. These predicate/marketed devices include:

Sorin Biomedical - (BCC) - Blood Cardioplegia Console (K942582) Quest Medical Inc. - (MPS) - Myocardial Protection System (K953838) Sarns/3M - Sarns 9000 Heart Lung Console (K871131) Medtronic, Inc. Cardiopulmonary - CardioTherm™ Blood Cardioplegia Delivery System (K960755) - Disposable component only ... _... ..

In determining substantial equivalence of the CSS" Cardioplegia Safety System, the decisionmaking process follows the 510(k) "Substantial Equivalence" flow diagram, and is presented as follows:

The CSS" Cardioplegia Safety System is being "compared to the following Marketed Devices":

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Sorin Biomedical (BCC) Blood Cardioplegia Console (K942582) .
Quest Medical Inc. (MPS) Myocardial Protection System (K953838) .
Sarns/3M Sarns 9000 Heart Lung Console (K871131) .
CardioTherm™ Blood Cardioplegia Delivery System (K960755) .

The CSS" Cardioplegia Safety System has the "same indications statement and intended use" as the predicate/marketed devices

CSS™ Cardioplegia Safety System

The Medtronic CSS" Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

Sorin Blood Cardioplegia Console ("BCC")

Ouest MPS Myocardial Protection System

The Quest MPS Myocardial Protection System is intended for use by perfusionists and surgeons trained in delivering cardioplegia solution to the myocardium during open heart surgerv

Sarns 9000 Cardioplegia Control Module

With Cardioplegia Control Module installed, the 9000 system is indicated to pump a set volume of cardioplegia fluid at a set pressure during cardiopulmonary bypass procedures.

CardioTherm™ Blood Cardioplegia System (Disposable)

The Medtronic CardioTherm Blood Cardioplegia System is intended for the mixing, cooling, warming and delivery of oxygenated blood and/or asanguineous cardioplegia solution.

The CSS" Cardioplegia Safety System has "new technological characteristics (e.g., design, materials and manufacturing processes)" from the predicate/marketed devices. Similar technological characteristics include;

· pump cardioplegia solutions at specified flow rates by varying the speed of the pump
· measure and display temperature (2)
measure and display pressure (2) .

Additional technological characteristics are provided in the Designed Specification and Design Features Tables.

Like the Quest MPS Myocardial Protection System, the CSS" Cardioplegia Safety System allows the user to introduce arresting agents (e.g. potassium) into the cardioplegia circuit at specified

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flow rates. The CSS" Cardioplegia Safety System does not offer a built in heater/cooler like the predicate/marketed devices, however, if heating and cooling of the cardioplegia solution is desired, an additional water line can be connected from the CardioTherm" heat exchanger to the heater/cooler used in the extracorporeal bypass circuit. This is a standard practice commonly used for this application.

These technological characteristics "could affect the safety and effectiveness of the device" However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are accepted scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been summarized below. These "performance data demonstrate" that the CSS" Cardioplegia Safety System is substantially equivalent to marketed devices.

SUMMARY OF TESTING PERFORMED

In-Vitro Bench Testing:

In-vitro bench testing was performed to ensure the CSS Cardioplegia Safety System operated in accordance with Medtronic Bio-Medicus device specifications, and in accordance with applicable established standards to ensure user and patient safety. These tests included:

The CSS" Instrument Disposable Set Integrity Test .
Pump Flow Performance .
Blood Trauma Test .
Disposable Pressure Drop .
. Occlusion and Maximum Pressure
Constant Pressure Mode Performance ●
. Line Pressure Measurement System Performance
External Pressure Measurement ●
. Gross Air Detection
. Disposable Chemical Resistance
Temperature Monitoring ●
. Environmental Testing
Battery Back-up ●
Syringe Pump Performance Test .
Auxiliary Output and Overcurrent Protection .
ESD Testing ●
EMI/EMC Immunity & Emissions Testing ●
. Dielectric and Chassis Leakage Test

Biocompatibility Testing:

The roller pump silicone tubing and polycarbonate connectors are the only components of the disposable set that are not currently marketed components in the CardioTherm" Blood Cardioplegia Systems (K960755). These materials are however commonly used in the medical industry for various applications, including blood contact devices. These devices were tested in

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accordance with the FDA Blue Book Memorandum - #G95-1, and Biological Evaluation of Medical Devices Guidance - International Standard ISO 10993-1 "External Communicating Devices, Circulating Blood" - Contact Duration of A - limited ≤ 24 hours, and in accordance with United States Pharmacopoeia - XXIII.

Based on the results of the biocompatibility testing performed, the materials used were determined to be biocompatible and nontoxic and, therefore, safe for their intended use.

Sterilization:

The CSS" Cardioplegia Sets will be sterilized in accordance with a validated 100% (EtO) ethylene oxide sterilization method at a minimum sterility assurance level (SAL) of 10th The EtO sterilization process process qualifications and validation are in accordance with criteria described in the American National Standards Institute, Inc. (ANSI) standard ANSI/AAMI/ISO 11135-1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization).

EtO Residuals:

EtO dissipation curves have been developed and will apply to routine product release to assure that all products meet the limits for residual concentrations of ethylene oxide and ethylene chlorohydrin, and ethylene glycol as published in ANSI Standard Number ANSI/AAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals).

Pyrogen Testing:

Routine Pvrogen Testing will be performed using the Limulus Amebocyte Lysate (LAL) method. Product testing and release criteria (less than .5 EU/ml) is in accordance to the December, 1987 Guidelines issued by the Food and Drug Administration, Office of Compliance ("Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices").

CONCLUSION

Based on the information presented above, the CSS Cardioplegia Safety System demonstrates substantial equivalence to the predicate/marketed devices, and the CSS" Cardioplegia Safety System is safe for its intended use.

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SPECIFICATION






DESIGN




















COMPARISON OF I

Feature	Medtronic CSSThe Medtronic CSST™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors and delivers oxygenated blood and/or asanguineous solutions during cardio-pulmonary bypass procedures.	Sorin BCCThe Sorin Blood Cardioplegia Console ("BCC") is intended for use by qualified personnel during cardiopulmonary bypass procedures to control and monitor the introduction of blood and/or crystalloid in the management of cardioplegia.	Quest MPSThe Quest MPS Myocardial Protection System is intended for use by perfusionists and surgeons trained in delivering cardioplegia solution to the myocardium during open heart surgery	Sarns 9000With Cardioplegia control Module installed, the 9000 system is indicated to pump a set volume of cardioplegia fluid at a set pressure during cardio-pulmonary bypass procedures.
Intended Use:
Power	110/220 VAC 50-60 Hz	115 VAC 60 Hz94-128 VAC	110/220 VAC 50-60 Hz	115/220 VAC 50-60 Hz103-126V
Power Accuracy	+/- 10%		not available
Pressure Range	0-500 mmHg	0-550 mmHg	0-600 mmHg	-45 - 990 mmHg
Line Pressure Accuracy	line pressure 0-100 mmHg +/-10 mmHgline pressure 101-500 mmHg +/-10%	+/- 5 mmHg	+/-2.5% or 3mmHg under all conditions	< 500 mmHg +/-10 mmHg500 mmHg +/- 20 mmHg
External Pressure Accuracy	external pressure 0-100 mmHg +/- 5 mmflgexternal pressure 101-500 mm Hg +/-5%	+/- 5 mmllg	+/- 2.5% or 3mmlig under all conditions	< 500 mmHg +/-10 mmHg500 mmHg +/- 20 mmHg
Constant Pressure Mode	pressure is maintained at +/-15% of target pressure; the flow required to maintain pressure varies no more than +/-25%	N/A	flow rate limits are adjustable by operator	N/A
Tolerance
Flow Rate	0-990 mL/min	10-600 mL/min	0-500 mL/min	0-9.8 L/min
Flow Accuracy	0-600 +/- 10% *601-990 +/- 20%	+/-5%	+/-5%	0-2 L/min +/-.1 L/min2-6 L/min +/-.2 L/min> 6 L/min +/-.3 L/min
Flow Ratios (Blood:Crystalloid)	0:1, 1:1, 2:1, .... 9:1 &1:0, 1:1, 1:2, .... 1:9	0:1, 1:0, 1:1. 2:1, .... 16:1	0:1, 1:1, 2:1, .... 20:1 &1:0, 1:1, 1:2, ... 1:9	N/A
Temperature Range	0-50°C	0-40°C	0-39°C	0-49.9°C
Temperature Accuracy	+/-1°C	+/-1°C	+/-1°C	+/-.2°C
Timer Range	0-99hr59min59sec	0-99.9 ınin	N/A	cardioplegia timer range is 0-1 hour, auxiliary tiner range is 0 - 24 hours; clamp and puinp timer range is 0-10 hours
Timer Accuracy	1 sec	.1 min	N/A	cardioplegia timer accuracy is +/- 1 min
Weight	11 kg	40 kg	22 kg	unknown
Display	LCD	LCD	LCD	LCD and CRT
Splash Proof	Yes	Yes	Yes	Yes
UL	Yes, CUL	Yes	Unknown	Yes
CSA	Yes, CUL	Yes	Unknown	Yes
CE**	Yes	Uknown	Unknown	Unknown
Feature	Medtronic CSS	Sorin BCC	Quest MPS	Sarns 9000
AC Power	Yes	Yes	Yes	Yes
AC Power Backup	Battery backup- fully functional60 minutes of power-on time,including 15 minutes ofpumping at typical operatingparameters;	YesHandcrank: device operates ata reduced functionality whileon handcrank backup	No	Yes, battery backup andhandcrank
No. of Blood-Crystalloid Pumps	2; 1 blood & 1 crystalloid pump	2; 1 blood & 1 crystalloid pump	2; 1 blood & 1 crystalloid pump	1; blood/crystalloid pump
Type of Pump	Roller	Roller	Piston	Roller
Flow Units	mL/min	mL/min	mL/min	L/min or RPM
Flow Direction	one way, disposable can beconnected in only one way	both ways, depending on howdisposables are connected	one way, disposable can beconnected in only one way	both ways
Pulsatile Flow Control	No	No	No	Yes
Heater/Cooler	Separate and optional	Built-in	Built-in	Separate and optional
Temperature Sensor	Yes. 2 sensors	Yes. 2 sensors	Yes. 4 sensors	Yes, 3 sensors
Pressure Monitor	Yes, 1 internal sensor and 1external delivery sensor	Yes. 2 sensors	Yes, 2 internal sensors and 1external delivery sensor	Yes
Pressure Zeroing	Yes	Yes	Yes	Yes
Pressure Units	mmHg or kPa	mmHg or kPa	mmHg	mmHg or kPa
User Adjustable Pressure Limits	Yes	Yes	Yes	Yes
Pressure Alarm	Yes	Yes	Yes	Yes
Pressure Alert	Yes	No	Yes	Yes
Constant Pressure Mode	Yes	No	Yes	No
Volume Monitor	Yes	Yes	Yes	Yes
Volume Units	mL	mL	mL	cc
User Adjustable Volume Limit	Yes	No	Yes	No
Volume Alert/Alarm	Yes	No	Yes	No
Arresting Agent Delivery	Yes, optional	No	Yes, optional	No
Separate Monitor Screen	No, built-in	Yes	No, built-in	Yes
Gross Air Monitor	Yes	No	Yes	Yes
Gross Air Alarm/Alert	Yes	N/A	Yes	Yes
Specified disposable sets	Yes	No	Yes	No
Alarm Type	Audio and visual	Audio and visual	Audio and visual	Audio and visual
Timers	Yes, 2	Yes, 2	No	Yes, 4: 1 cardioplegia timer1 pump timer, 1 clamp timer,1 auxiliary timer

Based on customer input this accuracy is sufficient for this application
** Application will be filed before international release.

RESOLUTION WILL BE AT LEAST 300 DPI FOR ALL LINE ART AND HALFTONE INTERNATIONAL PERIODICALS

ここい18

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COMPARISON DESIGN FEATURE

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000019

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design, with three profiles facing right, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 1998

Mr. Thomas K. Johnson Product Regulations Manager Medtronic Cardiac Surgery Medtronic Bio-Medicus, Inc. 9600 West 76th Street Eden Prairie, MN 55344

K973237 Re: CSS™ Cardioplegia Safety System Regulatory Class: II (Two) Product Code: DWB Dated: January 26, 1998 Received: January 27, 1998

Dear Mr. Johnson: : ・・・・

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Thomas K. Johnson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callshan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

CSS™ Cardioplegia Safety System Device Name:

Indications For Use:

11 11:44

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ું જ્યાર The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated hlood and/or assanguineous cardioplegia solution during cardiopulmonary hypass procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
	Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	k 97 3237
Prescription Use	X
(Per 21 CFR 801.109
	OR Over-The-Counter-Use
	(Optional Format 1-2-96)

000007

Regulation Number and Section

§ 870.4370 Roller-type cardiopulmonary bypass blood pump.

(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).